Obesity Management for Kidney TRANSPLANTation: a Vanguard Study for an Innovative Randomized Controlled Trial, Embedded in Routine Care (OK-TRANSPLANT 2)
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
OK-TRANSPLANT 2 is a vanguard study for a large randomized, pragmatic, open-label trial. We will randomize participants with obesity, high-risk CKD/dialysis who are hoping for lose weight for the purpose of kidney transplant. Subjects will either be enrolled on a virtual weight management program or continue their usual care.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults aged 18 years or older
• BMI \> 35 kg/m\^2
• \>10% risk of ESKD requiring renal replacement therapy over 2 years or receiving dialysis
Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Heather LaPier, BSc
heather.lapier@sjhc.london.on.ca
519-646-6100
Time Frame
Start Date: 2024-09-26
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: Virtual Weight Management Program
A maximum tolerated dose of semaglutide (Ozempic/Wegovy) will be administered once weekly subcutaneously, up to a dose of 2.0 mg. Participants will also receive nutritional and movement advice, as well as virtual coaching once every 4 weeks for 6 months.
No_intervention: Usual Care
Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.
Related Therapeutic Areas
Sponsors
Leads: Western University, Canada
Collaborators: St. Michael's Hospital (Toronto, Canada), Queen Elizabeth II Health Sciences Centre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's